Morbid Obesity

POLICY NUMBER

L.7.01.431

DESCRIPTION

Bariatric surgery is a treatment for morbid obesity in patients who fail to lose weight with conservative measures. There are numerous gastric and intestinal surgical techniques available. While these techniques have heterogenous mechanisms of action, the result is a smaller gastric pouch that leads to restricted eating. However, these surgeries may lead to malabsorption of nutrients, or eventually to metabolic changes.

Bariatric surgery is performed to treat morbid (clinically severe) obesity. Morbid obesity is defined as a body mass index (BMI) greater than 40 kg/m² or a BMI greater than 35 kg/m² with associated complications including, but not limited to, diabetes, hypertension, or obstructive sleep apnea. Morbid obesity results in a very high-risk for weight-related complications, such as diabetes, hypertension, obstructive sleep apnea, and various types of cancers (for men: colon, rectal, and prostate; for women: breast, uterine, and ovarian), and a shortened life span. A morbidly obese man at age 20 can expect to live 13 fewer years than his counterpart with a normal BMI, which equates to a 22% reduction in life expectancy.

The first treatment of morbid obesity is dietary and lifestyle changes. Although this strategy may be effective in some patients, only a few morbidly obese individuals can reduce and control weight through diet and exercise. Most patients find it difficult to comply with these lifestyle modifications on a long-term basis.

When conservative measures fail, some patients may consider surgical approaches. A 1991 National Institutes of Health Consensus Conference defined surgical candidates as "those patients with a BMI of greater than 40 kg/m², or greater than 35 kg/m² in conjunction with severe comorbidities such as cardiopulmonary complications or severe diabetes." (See Policy Guidelines on how to calculate BMI.)

Resolution (cure) or improvement of type 2 diabetes after bariatric surgery and observations that glycemic control may improve immediately after surgery, before a significant amount of weight is lost, have promoted interest in a surgical approach to the treatment of type 2 diabetes. The various surgical procedures have different effects, and gastrointestinal rearrangement seems to confer additional anti-diabetic benefits independent of weight loss and caloric restriction. The precise mechanisms are not clear, and multiple mechanisms may be involved. Gastrointestinal peptides, eg, glucagon-like peptide-1 (1GLP-1), glucose-dependent insulinotropic peptide (GIP), and peptide YY (PYY), are secreted in response to contact with unabsorbed nutrients and by vagally mediated parasympathetic neural mechanisms. GLP-1 is secreted by the L cells of the distal ileum in response to ingested nutrients and acts on pancreatic islets to augment glucose-dependent insulin secretion. It also slows gastric emptying, which delays digestion, blunts postprandial glycemia, and acts on the central nervous system to induce satiety and decrease food intake. Other effects may improve insulin sensitivity. Glucose-dependent insulinotropic peptide acts on pancreatic beta cells to increase insulin secretion through the same mechanisms as GLP-1, although it is less potent. Peptide YY is also secreted by the L cells of the distal intestine and increases satiety and delays gastric emptying.

The following summarizes the differenttypes of bariatric surgery procedures.

1. Vertical-Banded Gastroplasty (CPT code 43842)

Vertical-banded gastroplasty was formerly one of the most common gastric restrictive procedures performed inthe United States, but has now been replaced by other restrictive procedures due to high rates of revisions and reoperations. In this procedure, the stomach is segmented along its vertical axis. To create a durable reinforced and rate-limiting stoma at the distal end of the pouch, a plug of the stomach is removed, and a propylene collar is placed through this hole and then stapled to itself. Because the normal flow of food is preserved, metabolic complications are uncommon. Complications include esophageal reflux, dilation, or obstruction of the stoma, with the latter two requiring reoperation. Dilation of the stoma is a common reason for weight regain. Vertical-banded gastroplasty may be performed using an open or laparoscopic approach.

2. Adjustable Gastric Banding (CPT code 43770—laparoscopy, surgical, gastric restrictive procedure; placement of adjustable gastric restrictive device [e.g., gastric band and subcutaneous port components])

Adjustable gastric banding involves placing a gastric band around the exterior of the stomach. The band is attached to a reservoir implanted subcutaneously in the rectus sheath. Injecting the reservoir with saline will alter the diameter of the gastric band; therefore, the rate-limiting stoma in the stomach can be progressively narrowed to induce greater weight loss, or expanded if complications develop. Because the stomach is not entered, the surgery and any revisions, if necessary, are relatively simple.

Complications include slippage of the external band or band erosion through the gastric wall. Adjustable gastric banding has been widely used in Europe. Two banding devices are approved by the FDA for marketing in the United States. The first to receive FDA approval was the LAP-BAND® (original applicant, Allergan, BioEnterics, Carpinteria, CA; now Apollo Endosurgery, Austin, TX). The labeled indications for this device are as follows:

"The LAP-BAND system is indicated for use in weight reduction for severely obese patients with a body mass index (BMI) of at least 40 or a BMI of at least 35 with one or more severe comorbid conditions, or those who are 100 lb or more over their estimated ideal weight according to the 1983 Metropolitan Life Insurance Tables (use the midpoint for medium frame). It is indicated for use only in severely obese adult patients who have failed more conservative weight-reduction alternatives, such as supervised diet, exercise and behavior modification programs. Patients who elect to have this surgery must make the commitment to accept significant changes in their eating habits for the rest of their lives."

In 2011, the FDA-labeled indications for the LAP-BAND were expanded to include patients with a BMI from 30 to 34 kg/m² with at least 1 obesity-related comorbid condition.

The second adjustable gastric banding device approved by the FDA through the premarket approval process is the REALIZE® model (Ethicon Endo-Surgery, Cincinnati, OH). Labeled indications for this device are:

“The [REALIZE] device is indicated for weight reduction for morbidly obese patients and is indicated for individuals with a BMI of at least 40 kg/m², or a BMI or at least 35 kg/m² with one or more comorbid conditions. The Band is indicated for use only in morbidly obese adult patients who have failed more conservative weight-reduction alternatives, such as supervised diet, exercise, and behavior modification programs.”

3. Open Gastric Bypass (CPT code 43846—gastric restrictive procedure, with gastric bypass for morbid obesity; with short limb [150 cm or less] Roux-en-Y gastroenterostomy)

The original gastric bypass surgeries were based on the observation that post-gastrectomy patients tended to lose weight. The current procedure involves both a restrictive and a malabsorptive component, with horizontal or vertical partition of the stomach performed in association with a Roux-en-Y procedure (i.e., a gastrojejunal). Thus, the flow of food bypasses the duodenum and proximal small bowel. The procedure may also be associated with an unpleasant “dumping syndrome,” in which a large osmotic load delivered directly to the jejunum from the stomach produces abdominal pain and/or vomiting. The dumping syndrome may further reduce intake, particularly in “sweets eaters.” Surgical complications include leakage and operative margin ulceration at the anastomotic site. Because the normal flow of food is disrupted, there are more metabolic complications compared to other gastric restrictive procedures, including iron deficiency anemia, vitamin B-12 deficiency, and hypocalcemia, all of which can be corrected by oral supplementation. Another concern is the ability to evaluate the “blind” bypassed portion of the stomach. Gastric bypass may be performed with either an open or laparoscopic technique.

Note: In 2005, CPT code 43846 was revised to indicate that the short limb must be 150 cm or less, compared with the previous 100 cm. This change reflects the common practice in which the alimentary (i.e., jejunal limb) of a gastric bypass has been lengthened to 150 cm. This length also serves to distinguish a standard gastric bypass with a very long, or very, very long gastric bypass, as discussed further here.

4. Laparoscopic Gastric Bypass (CPT code 43644—laparoscopy, surgical, gastric restrictive procedure; with gastric bypass and Roux-en-Y gastroenterostomy [Roux limb 150 cm or less])

CPT code 43644 was introduced in 2005 and described the same procedure as open gastric bypass, but performed laparoscopically.

5. Mini-Gastric Bypass (no specific CPT code)

Recently, a variant of the gastric bypass, called the mini-gastric bypass, has been popularized. Using a laparoscopic approach, the stomach is segmented, similar to a traditional gastric bypass, but instead of creating a Roux-en-Y anastomosis, the jejunum is anastomosed directly to the stomach, similar to a Billroth II procedure. This unique aspect of this procedure is not based on its laparoscopic approach but rather the type of anastomosis used. It should also be noted that CPT code 43846 explicitly describes a Roux-en-Y gastroenterostomy, which is not used in the mini-gastric bypass.

6. Sleeve Gastrectomy (CPT code 43775 – laparoscopy, surgical, gastric restrictive procedure; longitudinal gastrectomy [i.e., sleeve gastrectomy])

A sleeve gastrectomy is an alternative approach to gastrectomy that can be performed on its own, or in combination with malabsorptive procedures (most commonly biliopancreatic diversion with duodenal switch). In this procedure, the greater curvature of the stomach is resected from the angle of His to the distal antrum, resulting in a stomach remnant shaped like a tube or sleeve. The pyloric sphincter is preserved, resulting in a more physiologic transit of food from the stomach to the duodenum and avoiding the dumping syndrome (overly rapid transport of food through the stomach into intestines) seen with distal gastrectomy. This procedure is relatively simple to perform and can be done as an open or laparoscopic procedure. Some surgeons have proposed the sleeve gastrectomy as the first in a two-stage procedure for very high-risk patients. Weight loss following sleeve gastrectomy may improve a patient’s overall medical status and thus, reduce the risk of a subsequent more extensive malabsorptive procedure, such as biliopancreatic diversion.

7. Endoluminal (also called endosurgical, endoscopic, or natural orifice) bariatric procedures (no specific CPT code)

With endoluminal bariatric procedures, access to the relevant anatomic structures is gained through the mouth without skin incisions. Primary and revision bariatric procedures are being developed to reduce the risks associated with open and laparoscopic interventions. Examples of endoluminal bariatric procedures studies include gastroplasty using a transoral endoscopically guided stapler and placement of devices such as a duodenal-jejeunal sleeve and gastric balloon.

8. Biliopancreatic Diversion Procedure (also known as the Scopinaro procedure) (CPT code 43847— gastric restrictive procedure, with gastric bypass for morbid obesity; with small intestine reconstruction to limit absorption)

The biliopancreatic diversion (BPD) procedure, developed and used extensively in Italy, was designed to address drawbacks of the original intestinal bypass procedures that have been abandoned due to unacceptable metabolic complications. Many complications were thought to be related to bacterial overgrowth and toxin production in the blind, bypassed segment. In contrast, BPD consists of a subtotal gastrectomy and diversion of the biliopancreatic juices into the distal ileum by a long Roux-en-Y procedure. The procedure consists of the following components:

• A distal gastrectomy induces a temporary early satiety and/or the dumping syndrome in the early postoperative period, both of which limit food intake.

• A 200-cm long “alimentary tract” consists of 200 cm of ileum connecting the stomach to a common distal segment.

• A 300- to 400-cm “biliary tract” connects the duodenum, jejunum, and remaining ileum to the common distal segment.

• A 50- to 100-cm “common tract” is where food from the alimentary tract mixes with biliopancreatic juices from the biliary tract. Food digestion and absorption, particularly of fats and starches, are therefore limited to this small segment of bowel, i.e., creating a selective malabsorption. The length of the common segment will influence the degree of malabsorption.

Because of the high incidence of cholelithiasis associated with the procedure, patients typically undergo an associated cholecystectomy.

Many potential metabolic complications are related to biliopancreatic diversion, including, most prominently, iron deficiency anemia, protein malnutrition, hypocalcemia, and bone demineralization. Protein malnutrition may require treatment with total parenteral nutrition. Also, several case reports have noted liver failure resulting in death or liver transplant.

9. Biliopancreatic Diversion with Duodenal Switch (CPT code 43845—gastric restrictive procedure with partial gastrectomy, pylorus-preserving duodenoileostomy and ileoileosteomy [50 to 100 cm common channel] to limit absorption [biliopancreatic diversion with duodenal switch])

CPT code 43845, which specifically identifies the duodenal switch procedure, was introduced in 2005. The duodenal switch procedure is a variant of the biliopancreatic diversion previously described. In this procedure, instead of performing a distal gastrectomy, a sleeve gastrectomy is performed along the vertical axis of the stomach. This approach preserves the pylorus and initial segment of the duodenum, which is then anastomosed to a segment of the ileum, similar to the biliopancreatic diversion, to create the alimentary limb. Preservation of the pyloric sphincter is intended to ameliorate the dumping syndrome and decrease the incidence of ulcers at the duodeno-ileal by providing a more physiologic transfer of stomach contents to the duodenum. The sleeve gastrectomy also decreases the volume of the stomach and decreases the parietal cell mass. However, the basic principle of the procedure is similar to that of the biliopancreatic diversion, i.e., producing selective malabsorption by limiting the food digestion and absorption to a short common ileal segment.

10. Long-Limb Gastric Bypass (i.e., >150 cm) (CPT code 43847—Gastric restrictive procedure with gastric bypass for morbid obesity; with small intestine reconstruction to limit absorption)

Variations of gastric bypass procedures have been described, consisting primarily of long-limb Roux-en-Y procedures, which vary in the length of the alimentary and common limbs. For example, the stomach may be divided with a long segment of the jejunum (instead of ileum) anastomosed to the proximal gastric stump, creating the alimentary limb. The remaining pancreaticobiliary limb, consisting of stomach remnant, duodenum, and length of proximal jejunum, is then anastomosed to the ileum, creating a common limb of variable length in which the ingested food mixes with the pancreaticobiliary juices. While the long alimentary limb permits absorption of most nutrients, the short common limb primarily limits absorption of fats. The stomach may be bypassed in a variety of ways (eg, resection or stapling along the horizontal or vertical axis). Unlike the traditional gastric bypass, which is a gastric restrictive procedure, these very long-limb Roux-en-Y gastric bypasses combine gastric restriction with some element of malabsorptive procedure, depending on the location of the anastomoses. Note that CPT code for gastric bypass (43846) explicitly describes a short limb (<150 cm) Roux-en-Y gastroenterostomy, and thus would not apply to long-limb gastric bypass.

11. Laparoscopic Malabsorptive Procedure (CPT code 43645—Laparoscopy, surgical, gastric restrictive procedure; with gastric bypass and small intestine reconstruction to limit absorption)

CPT code 43645 was introduced in 2005 to specifically describe a laparoscopic malabsorptive procedure. However, the code does not specifically describe any specific malabsorptive procedure.

12. Laparoscopic Gastric Plication (no specific CPT code)

Laparoscopic gastric plication is a bariatric surgery procedure that involves laparoscopic placement of sutures over the greater curvature (laparoscopic greater curvature plication) or anterior gastric region (laparoscopic anterior curvature plication) to create a tube-like stomach. The procedure involves 2 main steps, mobilization of the greater curvature of the stomach and suture plication of the stomach for achieving gastric restriction, but specifics of the technique are not standardized.

Weight Loss Outcomes

There is no uniform standard for reporting results of weight loss or for describing a successful procedure. Common methods of reporting the amount of body weight loss are the percent of ideal body weight achieved or percent of excess body weight (EBW) loss, with the latter most commonly reported. Excess body weight is defined as actual weight minus “ideal weight” and “ideal weight” and is based on 1983 Metropolitan Life Insurance height-weight tables for “medium frame.”

These two reporting methods are generally preferred over the absolute amount of weight loss because they reflect the ultimate goal of surgery: to reduce weight to a range that minimizes obesity-related morbidity. Obviously, an increasing degree of obesity will require a greater amount of weight loss to achieve these target goals. There are different definitions of successful outcomes, but a successful procedure is often considered one in which at least 50% of EBW is lost, or when the patient returns to within 30% of ideal body weight. The results may also be expressed as the percentage of patients losing at least 50% of EBW. The table below summarizes the variations in reporting weight loss outcomes.

Weight Loss Outcomes

BMI: body mass index; EBW: excess body weight.

Durability of Weight Loss

Weight change (ie, gain or loss) at yearly intervals is often reported. Weight loss at one year is considered the minimum length of time for evaluating these procedures; weight loss at 3 to 5 years is considered an intermediate time period for evaluating weight loss; and weight loss at 5 to 10 years or more is considered to represent long-term weight loss following bariatric surgery.

Short-Term Complications (Operative and Perioperative Complications <30 Days)In general, the incidence of operative and perioperative complications is increased in obese patients, particularly in thromboembolism and wound healing. Other perioperative complications include anastomotic leaks, bleeding, bowel obstruction, and cardiopulmonary complications (eg, pneumonia, myocardial infarction).

Reoperation RateReoperation may be required to “take down” or revise the original procedure. Reoperation may be particularly common in vertical-banded gastroplasty due to pouch dilation.

Long-Term Complications (Metabolic Adverse Events, Nutritional Deficiencies)Metabolic adverse events are of particular concern in malabsorptive procedures. Other long-term complications include anastomotic ulcers, esophagitis, and procedure-specific complications such as band erosion or migration for gastric banding surgeries.

Improved Health Outcomes in Terms of Weight-Related ComorbiditiesAside from psychosocial concerns, which may be considerable, one motivation for bariatric surgery is to decrease the incidence of complications of obesity, such as diabetes, cardiovascular risk factors (ie, increased cholesterol, hypertension), obstructive sleep apnea, or arthritis. Unfortunately, these final health outcomes are not consistently reported.

Forms of bariatric surgery performed without specific implantable devices are surgical procedures and, as such, are not subject to regulation by the FDA.

The table below shows forms of bariatric surgery with implantable devices approved by the FDA through the premarket approval process.

FDA-Approved Bariatric Surgery Devices

FDA: Food and Drug Administration; PMA: premarket approval

In February 2017, the FDA issued a letter to health care providers discussing the potential risks with liquid-filled intragastric balloons in response to reports of 2 types of adverse events related to the balloons. Several dozen reports concerned spontaneous overinflation of the balloons, which caused pain, swelling, and vomiting. The second set of adverse event reports indicated that acute pancreatitis developed in several patients due to compression of gastrointestinal structures. These reports involved both ReShape (no longer marketed in the US) and ORBERA brands. The adverse events may require premature removal of the balloons.

In August 2017, the FDA issued a second letter to health care providers informing them of 5 unanticipated deaths occurring from 2016 through the time of the letter, due to intragastric balloons. The FDA recommended close monitoring of patients receiving these devices. In June 2018, the FDA reported that, since 2016, a total of 12 deaths occurred in patients with liquid-filled intragastric balloons worldwide; 7 of these deaths were in patients in the U.S.

In April 2020, the FDA provided an update on risks and continued to recommend that healthcare providers "instruct patients about the symptoms of life-threatening complications such as balloon deflation, gastrointestinal obstruction, and gastric and esophageal perforation and monitor patients closely during the entire duration of treatment for potential complications, including acute pancreatitis, spontaneous hyperinflation, and other potentially life-threatening complications."

POLICY

This is a group-specific policy. It applies only to those contracts which specifically include weight management and/or treatment of obesity as a benefit. It does not apply when weight management and/or treatment of obesity are specifically excluded by the individual contract.

Patients must be at least 18 years of age.

Medical Management

Covered Services

In accordance with the individual subscriber contract, the following services are considered medically necessary for patients with a Body Mass Index (BMI) of 30 or above, or a BMI of 27 or above in patients who also have documented hypertension, diabetes, or hyperlipidemia:

1. One physician counseling visit every 3 months. Services may include medically necessary labs and other diagnostic tests.

2. A maximum of 4 consultations per year with a registered dietitian for nutritional counseling.

3. Drug Therapies: Orlistat™ (Xenical). All eligible patients will be given an authorization lasting 3 months. Additional three-month extensions require documentation of weight loss of at least four pounds per month during the preceding three months.

Non-Covered Services

1. Multi-faceted dietary programs such as Optifast™, Health Management Resources™, Medifast™

2. Weight loss programs, such as Weight Watchers™, Diet Center™, Jenny Craig™

3. Non-prescription supplements and diet aids

4. Other anorexiant and weight loss drugs, including amphetamines

Surgical Management

The surgical treatment of morbid obesity is considered eligible for coverage for morbidly obese patients whose Benefit Plans indicate specific coverage for these procedures and who meet ALL the following criteria:

1. BMI of 40 or greater, or 35 or greater with documented hypertension, diabetes, or hyperlipidemia; OR be at least 100 pounds over or twice the ideal weight for frame, age, height and sex specified in the most recent Metropolitan Life Insurance Table;

2. Documentation that the condition of morbid obesity has been of at least five years duration;

3. Failed attempts at weight loss have been documented; and

4. No treatable metabolic cause for obesity, such as adrenal or thyroid disorders

The following surgical procedures are considered eligible for coverage for the morbidly obese individual who meets the preceding criteria:

Revision Bariatric Surgery

Revision surgery to address perioperative or late complications of a bariatric procedure is considered medically necessary. These include, but are not limited to, staple-line failure,obstruction, stricture, non-absorption resulting in hypoglycemia or malnutrition, weight loss of 20% or more below ideal body weight, or band slippage that cannot be corrected with manipulation or adjustment.

Revision of a primary bariatric procedure that has failed due to dilation of the gastric pouch or dilation proximal to an adjustable gastric band (documented by upper gastrointestinal examination or endoscopy) is considered medically necessary if the initial procedure was successful in inducing weight loss prior to pouch dilation, and the patient has been compliant with a prescribed nutrition and exercise program.

The following procedures/surgeries are considered investigational.

1. Jejunoileal bypass

2. Garren-Edwards gastric bubble

3. Gastric wrapping

4. Horizontal gastric partitioning/gastroplasty

5. Long limb (>150 cm) gastric bypass procedures (essentially a malabsorptive procedure similar in concept to the biliopancreatic bypass)

6. "Mini-Gastric bypass" (Gastric bypass using a Billroth II type of anastomosis) (added 10-8-2002)

7. Bariatric surgery as a cure for type 2 diabetes mellitus

8. Biliopancreatic bypass without duodenal switch

9. Endoscopic procedures (e.g., insertion of the StomaphyX™ device) as a primary bariatric procedure or as a revision procedure to treat weight gain after bariatric surgery to remedy large gastric stoma or large gastric pouches

10. Laparoscopic gastric plication

POLICY EXCEPTIONS

Ryder System, Incorporation covers Surgical Treatment not Medical Management.

Federal Employee Program (FEP):  No benefits will be provided for outpatient surgery for morbid obesity unless the Member receives prior authorization from Blue Cross & Blue Shield of Mississippi.  Please refer to the FEP Service Benefit Plan for more details. FEP may dictate that all devices approved by the FDA (i.e., the Lap-Band device) may not be considered investigational and thus coverage eligibility of these devices may be assessed only on the basis of their medical necessity. 

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

To determine whether or not patients have responded to conservative measures for weight reduction, patients must have been active participants in non-surgical weight reduction programs that include frequent, e.g., monthly, documentation of weight, dietary regimen, and exercise. In general, patients must have participated in these programs for at least 6 months. These conservative attempts must be reviewed by the practitioner seeking approval for the surgical procedure.

Morbid obesity is defined as a body mass index (BMI) 40 kg/m² or more or a BMI 35 kg/m² or more with at least 1 clinically significant obesity-related disease such as diabetes, obstructive sleep apnea, coronary artery disease, or hypertension for which these complications or diseases are not controlled by best practice medical management. 

Patients with a BMI greater than or equal to 50 kg/m² may need a bariatric procedure to achieve greater weight loss. Thus, use of adjustable gastric banding, which results in less weight loss, should be most useful as one of the procedures used for patients with BMI less than 50 kg/m². Malabsorptive procedures, although they produce more dramatic weight loss, potentially result in nutritional complications, and the risks and benefits of these procedures must be carefully weighed in light of the treatment goals for each patient.

BMI is calculated by dividing a patient’s weight (in kilograms) by height (in meters) squared.

To convert pounds to kilograms, multiply pounds by 0.45

To convert inches to meters, multiply inches by 0.0254

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

1/1993: Approved by Medical Policy Advisory Committee (MPAC).

11/1998: Medical Management of Obesity approved by MPAC.

8/1999: Revisions to Surgery for Morbid Obesity approved by MPAC.

1/2000: Medical Management of Obesity and Surgery for Morbid Obesity policies merged; interim policy revisions.

2/2000: Interim policy revisions approved by MPAC.

3/22/2000: See POLICY EXCEPTIONS for First Chemical.

9/14/2000: Long limb (>100 cm) gastric bypass procedures are investigational and not covered. See Surgical Management.

1/9/2001: See POLICY EXCEPTIONS for BancorpSouth.

2/2/2001: See POLICY EXCEPTIONS for Mississippi Power.

11/29/2001: See POLICY EXCEPTIONS for Ryder System, Incorporation.

1/7/2002: Singing  River (self insured group) will cover all 5 surgical procedures for morbid obesity added to POLICY EXCEPTIONS.

2/1/2002: Mid-Delta Home Health added to POLICY EXCEPTIONS.

2/13/2002: Investigational definition added.

3/8/2002: Prior authorization deleted. Policy Exceptions are Group Specific, Renal Care Group added to POLICY EXCEPTIONS.

5/1/2002: Type of Service and Place of Service deleted.

6/3/2002: CPT code 43848 moved to covered.

10/8/2002: Laparoscopic and other investigational procedures added to Surgical Management, Chevron/Texaco POLICY EXCEPTIONS added, Sources updated, Code Reference section updated.

3/3/2003: CPT code 43659 updated.

9/22/2003: FEP Policy Exception added, Biliopancreatic Bypass with Duodenal Switch added to CPT 43659, Biliopancreatic Bypass moved from CPT 43659 to CPT 43857.

11/2003: Reviewed by MPAC, no changes.

2/27/2004: Code Reference section updated.

4/22/2004: CPT code 43633 added.

8/18/2004: Policy Exception for Singing  River “Note: Singing  River  (self-insured group) effective 9/1/2004, there will be a $10,000 per lifetime limit on surgical treatment for morbid obesity and any resulting complications of such surgery. All surgical procedures must be prior authorized and all BCBSMS policy requirements under 'Surgical Management' section in effect at the time of the surgical procedure must be satisfied for coverage.” added.

10/21/2004: Metropolitan Life Height and Weight Tables added.

11/18/2004: Reviewed by MPAC, no changes, Sources updated.

1/5/2005: Short limb <100 cm changed to 150 cm or less, Code Reference section updated, CPT 43644 added covered codes, CPT 43659 note added, CPT 43846 description revised, ICD-9 procedure code 44.68, 44.96 added covered codes, HCPCS S2085 deletion date of 12/31/2004 added, CPT 43645, 43845 added non-covered codes, CPT 43659 note added non-covered codes, CPT 43847 description revised and note added, ICD-9 procedure code 44.93, 44.94, 44.95, 44.97, 44.98, 44.99, 97.86 added non-covered codes, HCPCS S2082, S2083 added non-covered codes.

2/8/2005:  Singing River  clarification "Only the surgical procedures listed under 'Surgical Management' section as identified by 'eligible for coverage' are covered. Those procedures/surgeries that are listed as 'investigational' are not covered regardless of medical necessity" added.

11/8/2005: Code Reference Section updated, ICD9 diagnosis codes V85.23-V85.25, V85.30-V85.39, V85.4 added.

2/2/2006:  Policy Exception section updated, prior authorization requirement was removed from BancorpSouth.

3/15/2006: Coding updated. CPT4/HCPCS 2006 revisions added to policy.

3/20/2006: Policy reviewed, no changes.

6/13/2006: Policy updated. Singing River (a self-funded group) will cover Gastric Banding/Lap Band procedure effective 9/1/2004.

8/28/2006: Policy updated. Sleeve gastrectomy, when done as the sole procedure, is considered investigational.

9/19/2006: Coding updated. ICD9 2006 revisions added to policy.

12/15/2006: Policy exceptions section updated. Removed prior authorization requirement and revised exceptions language for Singing River.

12/21/2006: Policy Exceptions updated. Removed Mississippi Power (group cancelled 12-31-2005), Chevron/Texaco (group cancelled 01-01-2005), and Renal Care Group (group cancelled 12-31-2006).

1/9/2007: Policy Exceptions section for Bancorp South updated to include Lap Band surgery.

1/22/2007: Policy Exceptions updated for Federal Employee Program (FEP); added "prior to January 1, 2007" to existing exceptions, and added "NOTE: For FEP subscribers only, January 1, 2007, and after refer to the SBP."

5/17/2007: Policy Exceptions clarified for Singing River, one morbid obesity surgical procedure and all ongoing related services are covered up to the $10,000 per lifetime maximum.

12/19/2007: Coding updated per 2008 CPT/HCPCS revisions.

1/11/2008: Policy exceptions clarified; no change in policy.

2/11/2008: Policy statement rewritten for clarity; no change in policy.

3/28/2008: Code reference section updated. CPT codes 43770-43774, 43886-43888, HCPCS code S2083, ICD-9 procedure codes 44.95, 44.97, 44.98 moved to covered.

7/30/2010: Policy description updated to include detailed descriptions of gastric restrictive procedures and malabsorptive procedures. Policy statement section updated to include open or laparoscopic biliopancreatic bypass (the Scopinaro procedure) with duodenal switch may be medically necessary, biliopancreatic bypass without duodenal switch, bariatric surgery as a cure for type 2 diabetes mellitus and endoscopic procedures are considered investigational. Policy exception section updated to include gastric sleeve coverage effective 5-1-2010 for Singing River and Mid Delta Home Health coverage language deleted. FEP Service Benefit plan language deleted. FEP prior authorization requirement and FDA language added to policy exception section. Policy guidelines section updated to include detailed information regarding patient selection criteria and BMI calculation. Code reference section updated: Description revised for CPT codes 43659 and 43846. CPT code 43845 added to covered table, ICD-9 diagnosis code 997.4 added to covered table, HCPCS code S9452 added to covered table.

10/19/2010: Annual ICD-9 code update: V85.4 deleted/expanded to the fifth digit. Added V85.41-V85.45 to the Covered Codes table.

08/19/2011: Policy statement revised to state that the patient must be at least 18 years of age instead of 21. Re-formatted the information in the policy statement regarding surgical procedures; intent unchanged. Policy statement revised to change sleeve gastrectomy, when done as the sole procedure from investigational to medically necessary. Added information regarding further bariatric surgery and revision bariatric surgery to the policy statement. Deleted Outdated references from the Sources section.

01/22/2014: Added band slippage that cannot be corrected with manipulation or adjustment as an indication for bariatric surgery revision.

07/30/2015: Policy description updated regarding types of bariatric surgery procedures. Policy statement for revision bariatric surgery revised to state that: Revision of a primary bariatric procedure that has failed due to dilation of the gastric pouch or dilation proximal to an adjustable gastric band (documented by upper gastrointestinal examination or endoscopy) is considered medically necessary if the initial procedure was successful in inducing weight loss prior to pouch dilation, and the patient has been compliant with a prescribed nutrition and exercise program. Added laparoscopic gastric plication as investigational. Policy exceptions section updated to remove language for BancorpSouth. Policy guidelines updated to add medically necessary and investigative definitions.

08/31/2015: Code Reference section updated for ICD-10. ICD-9 diagnosis code 997.4 extended to the fifth digit as 997.49. Removed deleted ICD-9 diagnosis code V85.4 and ICD-9 procedure codes 97.86 and 44.99. Removed outdated group exceptions from the Policy Exceptions section.

06/09/2016: Policy number L.7.01.431 added.

08/04/2016: Policy description updated. Policy statements unchanged.

08/02/2017: Policy description updated regarding devices. Policy statements unchanged.

09/29/2017: Code Reference section updated to add new ICD-10 diagnosis codes K91.30, K91.31, and K91.32. Effective 10/01/2017.

03/13/2018: Policy description updated regarding weight loss outcomes and devices. Policy statements unchanged.

03/28/2019: Policy reviewed; no changes. Code Reference section updated to remove deleted ICD-10 diagnosis code K91.3.

09/24/2019: Code Reference section updated to revise description for ICD-10 diagnosis code Z68.43, effective 10/01/2019.

10/01/2020: Code Reference section updated to revise code descriptions for ICD-10 diagnosis codes Z68.27, Z68.28, Z68.29, Z68.30, Z68.31, Z68.32, Z68.33, Z68.34, Z68.35, Z68.36, Z68.37, Z68.38, Z68.39, Z68.41, Z68.42, Z68.43, Z68.44, and Z68.45, effective 10/01/2020.

08/23/2021: Policy description updated regarding devices. Policy statements unchanged. Policy Guidelines updated to define morbid obesity and change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

06/22/2022: Policy description updated regarding devices. Policy statements unchanged.

11/28/2022: Policy reviewed; no changes.

12/19/2022: Code Reference section updated to add new CPT codes 43290 and 43291, effective 01/01/2023.

12/08/2023: Policy reviewed. Policy statement updated to remove Meridia™ (Sibutramine) as this medication is no longer available in the U.S.

12/16/2024: Policy reviewed; no changes.

01/01/2026: Code Reference section updated to add new CPT code 43889.

SOURCE(S)

Blue Cross Blue Shield Association policy # 7.01.47

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy. 

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Covered Codes

 Investigational Codes

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